At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase IIa Proof of Concept, Multicenter, Randomized, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Combination M5717 Plus Pyronaridine Administered Once Daily for 1 or 2 Days to Adults and Adolescents With Acute Uncomplicated Plasmodium Falciparum Malaria (CAPTURE 1)
In Brief
A Phase 2 clinical trial evaluating M5717 330 mg, M5717 500 mg, and 4 other interventions for Acute Malaria. Completed, enrolled 38 participants across 5 sites in 4 countries.
Detailed Summary
The purpose of this study was to evaluate the safety, efficacy, and pharmacokinetic of the combination M5717 plus pyronaridine in participants with acute uncomplicated Plasmodium falciparum malaria.
Study Details
Timeline
Interventions
Participants will receive orally 330 mg granules of M5717 in combination with pyronaridine dispersed in water under fasting condition.
Adolescent participants with weight less than (\<) 45 kilograms (kg) will receive orally 500 mg granules of M5717 in combination with pyronaridine dispersed in water once daily under fasting condition.
Adult and adolescent participants with weight more than or equal to (\>=) 45 kg will receive orally 660 mg granules of M5717 in combination with pyronaridine dispersed in water once daily under fasting condition.
Participants will receive 360 mg of pyronaridine tablets in combination with M5717 under fasting condition.
Participants with weight \>=24 to \<45 kg will receive 360 mg of tablets in combination with M5717 under fasting condition.
Participants with weight \>=45 to \<65 kg will receive 540 mg of Pyronaridine tablets in combination with M5717 under fasting condition.
Participants with weight \>=65 kg will receive 720 mg of Pyronaridine tablets in combination with M5717 under fasting condition.